Clinical Evaluation of the PowerGlide™ Pro Midline Catheter

• Sponsor: University Hospital Augsburg (Other)
• Overall Status: Completed
• CT.gov ID: NCT06037525
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Actual Duration (Months): 63.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

Clinical evaluation of the PowerGlide™ Pro Midline Catheter in patients with vascular diseases

Condition or Disease	Intervention/Treatment	Phase
Pain; Catheter Infection	Device: PowerGlide™ Pro Midline Catheter

Detailed Description

Clinical evaluation of the PowerGlide™ Pro Midline Catheter in patients with vascular diseases. The selected patients are in need of a long-term i.v. therapy for reasons as antibiotic therapy or alprostadil therapy. The Midline catheter is a device, which is placed via Seldinger's technique to a vein usual on the upper extremity under ultrasound-control.

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clinical Evaluation of the PowerGlide™ Pro Midline Catheter
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Nov 13, 2020
• Actual Study Completion Date: May 1, 2023

Outcome Measures

Primary Outcome Measures

1. Dwelling Time [0-29 days]

   Length of catheter in situ time

Secondary Outcome Measures

1. Administration of Alprostadil [0-29 days]

   Feasibility for the usage of Alprostadil

2. Catheter Complications [0-29 days]

   Site complications as thrombophlebitis and occlusion

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• need for i.v. therapy longer than 7 days

• poor peripheral vein status

• Administration of alprostadil

Exclusion Criteria:

• pending dialysis

• allergy to catheter material

• minor age

• life threatening conditions

• requirement for central venous catheter

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Augsburg	Augsburg		Germany	86165

Sponsors and Collaborators

• University Hospital Augsburg

Investigators

• Study Director: Alexander Hyhlik-Duerr, PhD, University Hospital Augsburg Vascular Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital Augsburg
• ClinicalTrials.gov Identifier: NCT06037525
• Other Study ID Numbers: MIDLINE
• First Posted: Sep 14, 2023
• Last Update Posted: Sep 14, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 14, 2023